Letters Section Editor: Stephen J. Lurie,
MD, PhD, Senior Editor.
In Reply: Although we appreciate Dr Rosé's
argument for diversity, we contend that there is a point of diminishing returns
when diverse and redundant review interferes with uniform participant protection.
For instance, 23% of local IRBs deemed the same protocol to be eligible for
expedited review, while the others did not. This variability reveals serious
differences in the review process, not simply diversity. Differences in the
review process can manifest in several ways. For example, revisions mandated
by the different language requirements of local IRBs could have produced consent
forms that did not articulate the intended study protocol. Thus, we remain
concerned that the current system does not ensure equal protection of the
rights and welfare of human participants in large multicenter studies.
McWilliams R, Hoover-Fong J, Hamosh A, Beck S, Beaty T, Cutting GR. Local vs Central Institutional Review Boards for Multicenter Studies. JAMA. 2003;290(16):2126–2127. doi:10.1001/jama.290.16.2126-a
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